Sr. Specialist, QA Vendor Job

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

With guidance from the lab vendor quality lead, provides input to the lab vendor audit plan pertaining to clinical trial based services for vendors providing central and specialty lab services based on formal risk assessment criteria as it pertains to ongoing vendor compliance to operational standards and regulatory requirements. Primary responsibilities are focused on execution of the audit plan producing quality audit deliverables within required timeframes. In addition, pro-active quality support is required through engagement on issues as part of vendor governance operational activities, serious quality issues investigations, and other venues where trends may be identified.

Suggestions for improved quality are communicated to both the research business and the supporting vendors. Collaborates on quality issues information sharing and tasks with other research business quality functions to enable achievement of quality goals at the clinical trial protocol level. A detailed understanding of applicable regulations/guidances is required along with the ability to rapidly assess a vendor’s policies/procedures during audits and assessments. Vendor oversight methods and processes are employed in order to minimize and mitigate both operational and regulatory risks.

Primary activities include but are not limited to :

- Under the guidance of the lab vendor quality lead, provide support in the development of the MRL QA vendor audit plan pertaining to laboratory based vendor services using formal risk assessment criteria aligned with MRL standards and regulatory requirements. Engage with the research business areas to obtain appropriate input to the plan.

- With support from the lab vendor quality lead, implement the audit plan through execution of audit processes including audit scoping, audit conduct at vendor sites, and reporting of audit issues to MRL QA management and appropriate research business areas.

- Engage in follow up activities related to audit outcomes including additional audit reviews/assessments, meetings with the research business areas and/or vendors, and identification of audit outcome metrics to be reported to the MRL vendor management function.

- Subject matter expertise (SME) in a quality oversight role on various laboratory services used in support of clinical trials which includes but is not limited to: centralized safety testing, bioanalytical PK testing, biologics & vaccine testing, translational molecular biomarkers, and companion diagnostics with a fundamental understanding of the equipment/instrumentation used to support the testing. The SME role requires engagement with research business areas as part of formal operational governance forums, other ad hoc issues related to quality, and investigative interactions with other quality organizations in the research business areas.

- Build effective working relationships with key research business areas and vendor quality representatives.

- Engages with business quality groups to assimilate protocol level events and activities impacted by vendor performance as part of serious quality investigations, quality trending, and quality oversight.

- Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations, safety guidelines and company policies and procedures.

- Contribute to the ongoing development of MRL QA operating standards, work instructions, and training materials to further develop competencies within the MRL QA Vendor group and any other MRL QA areas assisting in support of the vendor quality program.

- Up to 25% domestic and international travel

Qualifications

Education:

- BS/BA in relevant area

Required:

- A minimum of 5 years of experience in the pharmaceutical industry

Preferred:

- Fundamental understanding of GLPs/GCPs and CAP/CLIA certifications.

- Experience with QA

- Vendor quality oversight activities

- Work history in laboratory testing used in clinical trials

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

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